Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-IOR-16009721 |
Date of registration:
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2016-11-03 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A clinical study of hydrogen-rich solution in kidney transplantation from marginal allograft
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Scientific title:
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A clinical study of hydrogen-rich solution using for marginal renal allograft in kidney transplantation -- a single center, randomized, controlled, double-blinded study |
Date of first enrolment:
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2016-11-01 |
Target sample size:
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HRS Group:50;Controlled group:50; |
Recruitment status: |
Recruiting |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=13483 |
Study type:
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Interventional study |
Study design:
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Randomized parallel controlled trial
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Gang Chen
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Address:
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1095 Jiefang Avenue, Wuhan, Hubei, China
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Telephone:
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+86 13006187015 |
Email:
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gchentj@vip.163.com |
Affiliation:
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Institute of Organ Transplantation, Tongji Hospital, Tongji Medical School, University of Huazhong Science and Technology |
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Name:
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Lan Zhu
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Address:
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1095 Jiefang Avenue, Wuhan, Hubei, China
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Telephone:
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+86 13971570206 |
Email:
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susanne.zhu@qq.com |
Affiliation:
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Institute of Organ Transplantation, Tongji Hospital, Tongji Medical School, University of Huazhong Science and Technology |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. DCD donor aged 18-65 years male or female;
2. Last sereum creatinine of DCD donors before donation should be >150umol/L;
3. Patienst would recieve the first time renal translantation due to uremia;
4. Recipients aged 18-60 years male or female;
5. Patients willing to voluntee to participate, and to sign an informed consent form.
Exclusion criteria: 1. Pateints who do not meet the inclusion criteria;
2. Patients who are HLA presensitized before renal transplantation,including patients either with positive PRA or a history of pretransplantation;
3. Patients who have high risk of recurrence disease after renal transplantation (FSGS,IgA nephropathy);
4. Patients who would undergo multi-organ transplantation;
5. Patients who are pregnant orlactating.
Age minimum:
18
Age maximum:
60
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Delayed graft function in kidney transplantation
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Intervention(s)
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HRS Group:Hydrogen-rich solution;Controlled group:regular solution;
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Primary Outcome(s)
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rate of Delayed Graft Function(DGF);
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Secondary Outcome(s)
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serum creatinine;eGFR;HMGB-1;
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Source(s) of Monetary Support
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Funds from Miz company in Japan and self-raised
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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